510(k) · Cleared
Recalled · Class II · 2020Toxcup Drug Screen Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Branan Medical Corp. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Feb 7, 2013 as substantially equivalent to K082898 (Amedica Biotech, Inc., 2008) after a 162-day review. Its family tree reaches back 1 generation to 2008. It has been recalled 8 times.
- Decided
- Feb 7, 2013
- Review
- 162 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082898 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK082898 Amedica Drug Screen Test CupAmedica Biotech, Inc. · 2008 · Recalled
- This deviceK122633 Toxcup Drug Screen CupBranan Medical Corp. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082898 | Amedica Drug Screen Test Cup | Amedica Biotech, Inc. | 2008 | 2 |
| 0 (this device) | K122633 | Toxcup Drug Screen Cup | Branan Medical Corp. | 2013 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LDJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LDJ device
- #1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082898 | Amedica Drug Screen Test CupSummary page 2…JXN 11 862.3700 Propoxyphene Test System Device Classification Class 11 Substantially Equivalent Devices K082898 - Amedica Home Drug Test U~p 140 Technology Dr, Suite 4oo, Irvine, CA 92618 e-mail: in… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 18, 2020 | Class II | Z-3032-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Aug 18, 2020 | Class II | Z-3047-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Aug 18, 2020 | Class II | Z-3033-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Aug 18, 2020 | Class II | Z-3039-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Aug 18, 2020 | Class II | Z-3031-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Aug 18, 2020 | Class II | Z-3035-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Aug 18, 2020 | Class II | Z-3040-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Aug 18, 2020 | Class II | Z-3045-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LDJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDJ
48in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDJ
1in 2015
MAUDE reports naming product code LDJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 4 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 219 | 0 | 0 |
| 2012 | 4 | 193 | 0 | 0 |
| 2013 | 3 | 162 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 48 | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ToxCup® Drug Screen Cup is an in vitro screening test for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration: AMP Amphetamine 500 ng/ml BAR Secobarbital 300 nglml BUPG Buprenorphine Glucuronide 10 ng/ml BZO Oxazepam 300 ng/ml COC Benzoylecgonine 150 nglml MDMA 3,4-methylenedioxymethamphetamine 500 ng/ml MET Methamphetamine 500 ng/ml MTD Methadone 300 ng/ml OPI Morphine 300 ng/ml…
Read the full statement (218 words)
The ToxCup® Drug Screen Cup is an in vitro screening test for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration:
AMP Amphetamine 500 ng/ml
BAR Secobarbital 300 nglml
BUPG Buprenorphine Glucuronide 10 ng/ml
BZO Oxazepam 300 ng/ml
COC Benzoylecgonine 150 nglml
MDMA 3,4-methylenedioxymethamphetamine 500 ng/ml
MET Methamphetamine 500 ng/ml
MTD Methadone 300 ng/ml
OPI Morphine 300 ng/ml
OXY Oxycodone 100 ng/ml
PCP Phencyclidine 25 ng/rnl
PPX Propoxyphene 300 ng/ml
TCA Nortriptyline 1000 ng/ml
THC 11-nor-A9-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml
These tests provide visual qualitative results and are intended for in vitro diagnostic use only. The ToxCup® Drug Screen Cup is available in double drug analyte cassette dip format. It is intended for prescription point-of-care use and over-the-counter consumer use.
These tests provide only a preliminary test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is confirming the results in a certified laboratory. For a quantitative result or to confirm preliminary positive results obtained by the ToxCup® Drug Screen Cup, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when a preliminary positive result is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122633 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122633: Toxcup Drug Screen Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122633
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026